U.S. patent number 6,179,786 [Application Number 09/385,387] was granted by the patent office on 2001-01-30 for system for thermometry-based breast cancer risk-assessment.
This patent grant is currently assigned to Profemme Ltd.. Invention is credited to David E. Young.
United States Patent |
6,179,786 |
Young |
January 30, 2001 |
System for thermometry-based breast cancer risk-assessment
Abstract
The system provides analogue electronic sensor means, novel
mechanical harness mounting means having adjustment means and
provided with remote attached monitor control means for sampling
breast surface temperature and means for collecting, storing and
displaying these data. The system allows breast temperatures to be
measured, with great reliability, for periods of an hour or more at
any desired rational sampling rate. Collected breast surface
temperature data may then be downloaded into a computer for
elaboration using proprietary software. Breast surface temperatures
are measured at a specific point during the menstrual cycle,
determined by progesterone levels in the urine. The data obtained
with the instant invention under these conditions enables an
investigator to determine, in women who have not reached the
menopause, those who are at risk of developing breast cancer at
some time in the future and those who are not at significant risk
of developing the disease.
Inventors: |
Young; David E. (Watlington,
GB) |
Assignee: |
Profemme Ltd. (Witney,
GB)
|
Family
ID: |
46203676 |
Appl.
No.: |
09/385,387 |
Filed: |
August 30, 1999 |
Current U.S.
Class: |
600/549; 600/372;
600/382; 600/386; 600/388 |
Current CPC
Class: |
A61B
5/015 (20130101); A61B 5/20 (20130101); A61B
2560/045 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); A61B 5/20 (20060101); A61B
005/00 (); A61B 005/04 () |
Field of
Search: |
;600/549,388,386,389,390,393,382,372,306,300,551 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
PCT/US90/02203 |
|
Nov 1990 |
|
EP |
|
2 203 250 |
|
Oct 1988 |
|
GB |
|
Other References
Simpson, Griffiths et al., "The lutoal heat cycle of the breast in
health", 27 Breast Cancer Research and Treatment, 239-45 (1993).
.
Sir James Young Simpson, Memorial lecture 1995 "Breast Cancer
Prevention (a pathologist's approach)", J.R. Coll, Surg. Edinb., 41
(Jun. 1996). .
Simpson, et al., "The lutoal heat cycle of the breast in disease",
Breast Cancer Research and Treatment (1995). .
Simpson, et al., "A clinical test for breast pre-cancer". A Journal
of Chronobiological Research in Medicine, The. 1, N.1
(1995)..
|
Primary Examiner: O'Connor; Cary
Assistant Examiner: Natnithithadha; Navin
Attorney, Agent or Firm: Tilton, Fallon, Lungmus &
Chestnut
Parent Case Text
REFERENCE TO RELATED APPLICATIONS
This application is entitled to the benefit of the filing date of
Provisional Application No. 60/102,882, filed Oct. 2, 1998 with
respect to all subject matter common to both applications.
Claims
I claim:
1. A device for measuring surface temperatures of human breasts,
comprising:
a harness including a first contactor pad, a second contactor pad,
and a securing strap means associated with said first and second
contactor pads to secure one of said contactor pads concentrically
on each breast of the human subject, said first contactor pad
including a first array of temperature sensors exposed on a breast
contact surface thereof and said second contactor pad including a
second array of temperature sensors exposed on a breast contact
surface thereof to provide direct contact between each sensor of
the sensor arrays and the surface of the associated breast;
remote monitor means in communication with said first and second
arrays of temperature sensors, to which a multiplicity of breast
surface temperatures detected by the temperature sensors are
communicated at predetermined intervals, and wherein such
multiplicity of breast surface temperatures are stored as subject
data.
2. The device of claim 1, wherein said remote monitor means is
interfaced with a host computer, to which said subject data is
transmitted and compared to known standard breast surface
temperature data stored in said host computer.
3. The device of claim 2, wherein when said subject data is
calculated by said host computer to be substantially similar to the
said standard breast surface temperature data, an indication means
of said host computer indicates the subject has a low long term
risk of developing breast cancer; and
when said subject data is calculated by the host computer to be
higher by at least approximately 0.6.degree. C. than said standard
breast surface temperature data, said indication means indicates
the subject has a substantially higher than normal long term risk
of developing breast cancer.
4. The device of claim 3, wherein when said subject data is
calculated by the host computer to be higher by at least
approximately 1.2.degree. C. than said standard breast surface
temperature data, said indication means indicates the subject may
have breast cancer.
5. The device of claim 1, wherein each of said contactor pads
includes:
a soft, pliable inner layer having a central aperture, a front face
defining said breast contact surface, and a plurality of holes
therein to expose said sensors;
a soft, pliable outer layer having a central aperture concentric
with said central aperture of the inner layer; and
means for attachment to said securing strap means.
6. The device of claim 5, wherein each of said inner and outer
layers includes a neoprene sheet, and said front face of said inner
layer is a nylon sheet adhered to said neoprene sheet.
7. The device of claim 5, wherein said central apertures of the
inner and outer layers are larger than about 45 mm in diameter,
whereby average-sized areolar areas of the breasts of said subject
are not covered by said harness.
8. A device for measuring surface temperatures of human breasts,
comprising harness means provided with absolute temperature sensing
means in the form of substantially similar first and second arrays
each having a plurality of matched and calibrated sensor means and
having connection means extending between each of said sensor means
and a remote monitor means selectively connectable to an interface
means, said interface means interfacing with a host computer,
wherein:
said harness means is in the form of a harness comprising first and
second contactor pads disposed apart so as to provide one for each
breast of a human subject and anterior and posterior joining means
which also constitute securing means for securing said harness to
the human subject;
said first and second arrays of matched and calibrated sensor means
each being disposed apart on a breast contact surface of each of
said first and second contactor pads, respectively, and arranged
such that no obstruction to thermal transfer is interposed between
said sensor means and said human breast surfaces, said first and
second contactor pads being so constructed as to prevent heat loss
from all surfaces of said sensor means not in contact with said
human breast surfaces and;
said connection means comprising first and second cables in contact
with said first and second contactor pads and said remote monitor
means, each of said first and second cables having an outer
sheathing portion and an inner portion comprising a plurality of
connecting wires, one of said connecting wires from said first
cable extending from each of said sensor means forming said first
array to said remote monitor means and one of said connecting wires
from said second cable extending from each of said sensor means
forming said second array to said remote monitor means.
9. The device of claim 8, wherein said remote monitor means
comprises a housing provided with temperature monitoring cycle
initiating means, power supply means, electronics means for
selectively polling each of said sensor means of each of said first
and second arrays at predetermined intervals in order collect
output data therefrom, means for storing said data and means for
downloading said data via said interface means to said host
computer.
10. The device of claim 9, wherein said interface means comprises
an interface between said remote monitor means and said host
computer.
11. The device of claim 10, wherein said host computer comprises a
computer and dedicated software program for the manipulation,
elaboration and display of said data downloaded from said remote
monitor means.
12. The device of claim 8, wherein said harness is provided in only
one size to fit all subjects.
13. The device of claim 8, wherein said harness is adapted for use
without a brassiere.
14. The device of claim 8, wherein said harness is operable when
used with a brassiere.
15. The device of claim 8, wherein each of said first and second
contactor pads is constructed from an inner annular layer and an
outer annular layer substantially similar in size and shape to said
inner annular layer, said inner and outer annular layers being
formed as blanks from flexible, compressible and extensible sheet
materials having a closed cell construction, said blanks each being
adapted by the provision of an inner circular hole having a
diameter selected so as to extend at least to the areolar area of
the breasts of a majority of human females.
16. The first and second contactor pads of claim 15, wherein said
inner and outer annular layers constituting each of said first and
second contactor pads are joined together by overlaying one inner
layer substantially upon one outer layer and sewing right around
contiguous inner margins to form an inner sewn seam and contiguous
outer margins to form an outer sewn seam.
17. The first and second contactor pads of claim 16, wherein each
of said pads is provided with first and second extension tabs
disposed at opposite ends of a diameter, said extension tabs
constituting attachment means for said anterior and posterior
joining and securing means.
18. The device of claim 17, wherein said anterior joining and
securing means comprise adjustable strap means and said posterior
joining and securing means comprise openable and adjustable
securing strap means.
19. The device of claim 8, wherein each of said first and second
arrays comprises an equal number of sensors.
20. The device of claim 19, wherein said sensors are of the
`temperature-in-current-out` type.
21. The sensors of claim 20, wherein said sensors are of the type
AD592 supplied in a transistor can package of the generic type
TO-92, said sensors having stiff wire legs.
22. The device of claim 21, wherein each of said legs of said
sensors is pushed through said flexible compressible sheet material
of said inner contact pad layers such that said material renders
the punctures effected in said material self-sealed by close
compressive contact of said material against each of said legs.
23. The device of claim 22, wherein each of said legs of said
sensors protrudes through said flexible compressible sheet material
and engages one of a series of through holes in a small disc-like
moulding said holes being disposed 120.degree. apart near the
periphery of said moulding adapted by the provision of said holes
to receive said legs.
24. The device of claim 23, wherein said plurality of connecting
wires of said inner portions of said first and second cables are in
the form of a plurality of twisted wire pairs and a first
connecting wire of each twisted wire pair extends between a
connecting point on a first of said legs of one of said sensors and
said remote monitor means and a second connecting wire of each
twisted wire pair extends between a connecting point on a second of
said legs of the same said sensor and said remote monitor means,
said twisted wire pairs of said first cable connecting means
extending between said sensors of said first array and said remote
monitor means and said twisted wire pairs of said second cable
connecting means extending between said sensors of said second
array and said remote monitor means.
25. The cable connecting means of claim 8 wherein said outer
sheathing portions of said first and second cables are of different
visually distinct colors.
26. The device of claim 15, wherein a wiring layout in respect of
medially located sensor can packages mounted on each of said first
and second contactor pads comprises extending first and second said
twisted wire pairs provided by each of said first and second
cables, in opposite directions, laterally and around inner surfaces
of said inner seams of said inner circular holes of said first and
second contactor pads such that at respective points substantially
furthest away from points of entry and emergence of said first and
second outer cables from each of said first and second contactor
pads respectively, said first and second twisted pairs are passed
under and over one another and drawn against said inner surface of
said seam said first and second twisted pairs thence being routed
back to said medially located sensor can packages, said wiring
layout constituting anti-traction means for said sensor can
packages.
27. The device of claim 8, further comprising insulating means,
which also constitute flexible cushioning means and adhesive means,
in the form of a soft insulating and sealing compound introduced
intimately throughout the interior of said first and second
contactor pads.
28. The device of claim 9, wherein said remote monitor means is
provided with a plurality of channel means in the form of discrete
electronic channels and channel connecting means for connecting
said plurality of said sensors to said remote monitor means with
said plurality of said twisted wire pairs, each one of said
channels being adapted for connection to one of said sensors with
one of said twisted pairs thereby providing means for the receiving
of electronic signals from each one of said sensors into a discrete
electronic channel.
29. The device of claim 28, wherein said remote monitor means is
provided with means for individually calibrating each of said
sensors using a plurality of analogue multiplexing means to switch
in two calibration resistors for each of said individual sensors
and resistance values of said calibration resistors are selected to
establish both zero and absolute current values against calibrated
reference temperatures.
30. The device of claim 28, wherein said signals from each of said
sensors are analogue signals subsequently converted into digital
signals which are then fed into an operational amplifier for
conditioning such that said digital signals may be processed in a
microprocessor.
31. The device of claim 28, wherein said digital signals are stored
in a plurality of static RAM chips until said microprocessor is
instructed to download data to said host computer.
32. The device of claim 28, wherein system variables may be set
from within said host computer and downloaded via an RS232 link to
said remote monitor means, where selected values of said system
variables may be stored in a non-volatile EEPROM, from whence said
selected values are applied to the collection of said signals.
33. The device of claim 9, wherein said power supply for said
remote monitor means is provided by a battery.
34. The device of claim 30, wherein separate voltage levels are
used for said analogue and said digital parts of the circuit and
said voltage levels are controlled using regulator chips.
35. The device of claim 15 wherein said housing of the remote
monitor means is provided with temperature monitoring cycle
initiating means and a plurality of colored light emitting diodes
to indicate function and status.
36. The device of claim 8, wherein said interface means provides
plug-in charging and downloading means for a plurality of remote
monitors.
37. The device of claim 11, wherein said display of said data
derived from each of said sensors may include tabular numerical
form and pictorial graphic display of the temperatures, measured by
each of said sensors at each said polling, displayed in their
correct spatial positions on each subject breast.
38. A method for measuring temperatures on the surface of human
breasts of a subject, comprising the steps of:
securing a harness to a human subject using a securing strap means
such that a first contactor pad of said harness is disposed upon a
first breast and a second contactor pad of said harness is disposed
upon a second breast such that the nipple and areolar area of each
of said first and second breasts are respectively located
concentrically within an inner circular hole in each of said first
and second contactor pads, with a plurality of sensor can packages
of a first and second sensor array caused to lie directly upon the
respective skin surfaces of each of said first and second breast,
and said first and second contactor pads including absolute
temperature sensing means having substantially similar first and
second sensor arrays, respectively;
activating a temperature monitoring cycle initiating means
associated with a remote monitor means in communication with said
first and second sensor arrays to initiate a temperature monitoring
cycle for the collection of breast surface temperatures over a
selected period during which each of a plurality of sensors of said
first and second sensor arrays is polled at predetermined intervals
and data so collected is stored within said remote monitor
means;
at the end of said selected period of said temperature monitoring
cycle, said harness is doffed by said subject and said remote
monitor means is connected to an interface means of a host computer
by a cable connecting means; and
downloading said stored data from said remote monitor means to said
host computer under commands issued via a computer input
device.
39. The method of claim 38, wherein prior to the step of securing
the harness to the human subject, the day of ovulation is first
determined and thereafter serial daily progesterone levels are
measured to find day 17 of the menstrual cycle of the subject, and
then waiting until day 17 of one menstrual cycle.
40. The method of claim 39, wherein said selected period for said
temperature monitoring cycle is one hour.
41. The method of claim 40, wherein said predetermined intervals
for polling each of said sensors are each sixty seconds.
42. The method of claim 41, wherein said serial daily progesterone
levels are measured in saliva of the subject.
43. The method of claim 42, wherein determination of said day of
ovulation is accomplished by serial urine dip testing carried out
each morning following the last day of menses until a color change
is noted indicating that ovulation has occurred.
44. The method of claim 43, wherein breast surface temperatures so
determined during the first 45 minutes of any said temperature
monitoring cycle are discarded to compensate for a period of
equilibration of said harness to said human subject.
45. The method of claim 44, wherein breast surface temperature so
determined after the first 45 minutes of any said temperature
monitoring cycle are compared to known standard breast surface
temperature data and;
where breast surface temperature so determined is substantially
similar to said standard breast surface temperature data it may be
reasonably concluded that the luteal cycle of the subject woman is
present and this may indicate that there is a low long term risk of
developing breast cancer;
where breast surface temperature so determined is higher by at
least approximately 1.degree. F. or 0.6.degree. C. but by less than
2.degree. F. or 1.2.degree. C. than said standard breast surface
temperature data it may be reasonably concluded that the luteal
cycle of the subject woman is absent and this may indicate a
substantially higher than normal long term risk of developing
breast cancer and;
where breast surface temperature so determined is higher by
approximately 2.degree. F. or 1.20.degree. C. than said standard
breast surface temperature data it may be indicative of the
presence of active breast cancer.
46. The method of claim 38, further comprising the step of
recharging said remote monitor means in order that said remote
monitor means may be prepared for subsequent use on another
subject.
47. A device for measurement of temperatures on the surface of
human breasts, comprising a system having harness means provided
with temperature sensing means in the form of substantially similar
first and second arrays, each of said arrays having a plurality of
sensors and having connection means extending between each of said
plurality of sensors and a remote monitor means selectively
connectable to an interface means interfacing with a host computer
means,
said harness means being in the form of a harness comprising first
and second annular contactor pads, said annular contactor pads
being disposed apart from one another so as to provide a means for
harnessing each breast of a human subject, and further comprising
anterior and posterior joining means for securing said harness to
said human subject;
said first and second annular contactor pads each being adapted by
the provision of an inner circular hole having a diameter selected
so as to extend at least to the areolar area of the breasts of a
majority of human females when said breasts are respectively
located concentrically within said inner circular holes in said
first and second annular contactor pads;
said first and second arrays of sensors each being disposed apart
on a breast contact surface of each of said first and second
annular contactor pads respectively and arranged such that no
barrier to thermal transfer is interposed between said sensor means
and said human breast surfaces, said first and second annular
contactor pads preventing heat loss from all surfaces of said
sensor means not in contact with said human breast surfaces;
said connection means comprising first and second annular contactor
pads and said remote monitor means each of said first and second
cables having an outer sheathing portion and an inner portion
comprising a plurality of connecting wires, each of said connecting
wires from said first cable extending from each of said sensors
forming said first array to said remote monitor means and each of
said connecting wires from said second cable extending from each of
said sensors forming said second array to said remote monitor
means;
said remote monitor means comprising housing means in the form of a
case provided with temperature monitoring cycle initiating means,
power supply means to power an electronic means for electronically
selectively polling each of said sensor means for each of said
first and second arrays at rational intervals in order to collect
output data therefrom, means for storing said data and downloading
said data via said interface means to said host computer means;
said interface means comprising an interface between said remote
monitor means and said host computer means; and
said host computer means comprising a computer and dedicated
software program for the manipulation, elaboration and display of
said data downloaded from said remote monitor means.
48. The device of claim 47, wherein said harness is used without a
brassiere.
49. The device of claim 47, wherein said harness is used with a
brassiere.
50. The device of claim 47, wherein each of said first and second
annular contactor pads is constructed from an inner annular layer
and an outer annular layer substantially similar in size and shape
to said inner annular layer, said inner and outer annular layers
being formed from flexible, compressible and extensible
materials.
51. The first and second annular contactor pads of claim 50,
wherein said inner and outer annular layers constituting each of
said first and second annular contactor pads are joined together by
overlaying one inner layer substantially upon one outer layer and
sewing right around contiguous inner margins to form an inner sewn
seam and contiguous outer margins to form an outer sewn seam.
52. The device of claim 47, wherein said anterior joining and
securing means comprise adjustable strap means and said posterior
joining and securing means comprise openable and adjustable
securing strap means.
53. The sensors of claim 47, wherein said sensors are of a
temperature in--current out type.
54. The cable connecting means of claim 47, wherein said outer
sheathing portions of said first and second cables are of
different, visually distinct colors.
55. The device of claim 47, wherein a wiring layout in respect of
first and second medially disposed sensors on each of said first
and second contactor pads comprises laterally extending wiring
means in the form of first and second twisted pairs of connecting
wires provided by each of said first and second outer cables
respectively above, below and around inner surfaces of said inner
sewn seams of said inner circular holes of said first and second
contactor pads such that at respective points substantially
furthest away from points of entry and emergence of said first and
second outer cables from each of said first and second contactor
pads respectively, said first and second twisted pairs of
connecting wires are passed under and over one another and drawn
against said inner surfaces of said inner sewn seams, said first
and second twisted pairs of connecting wires also being routed
directly and medially to each of said first and second medially
disposed said sensors, said wiring layout constituting
anti-traction means for said sensors.
56. The remote monitor means of claim 47, wherein said remote
monitor means is provided with means for individually calibrating
each of said sensors using a plurality of analog multiplexing means
to switch in two calibration resistors for each of said individual
sensors and resistance values of said calibration resistors are
selected to establish both zero and absolute current values against
calibrated reference temperatures.
57. The device of claim 47, wherein said power supply for said
remote monitor means is provided by a battery.
58. The device of claim 47, wherein said remote monitor means are
provided with temperature monitoring cycle initiating means and a
plurality of colored light emitting diodes to indicate function and
status.
Description
FIELD OF THE INVENTION
The present invention is in the field of biotechnology and
specifically relates to the field of breast cancer screening in
women.
BACKGROUND TO THE PRESENT INVENTION--THE RELATED ART
For well over twenty years, thermometric assessment of the human
female breast surface has been under investigation as a tool in the
armamentarium of those concerned with the detection and treatment
of breast cancer.
GB 1,492,803 (expired) and U.S. Pat. No. 4,055,166 (expired), both
granted to Simpson and Green and of substantially identical
content, describe a garment which is a brassiere upon and within
which is mounted a plurality of sensors for the purpose of
measuring breast temperature over the menstrual cycle. They
referred to a menstrual cycle of breast heat amounting to a
variation in surface temperature of about 1.degree. C. which is
maximal about 3 days before the onset of menstruation. In the
preamble, it is made clear that the intention is to detect the
presence of actual cancers based on the observation that areas
adjacent to a cancerous growth may be "slightly warmer (say 1 or
2.degree. F.) than unaffected areas of the other breast" and that
comparison of the 24 hour temperature variation (circadian
variation) between normal and cancerous breasts have shown clear
differences in time structure.
These authors make an important structural distinction between
their brassiere device and the earlier breast surface measurements
which had been made in hospital environments with sensors fixed on
the skin. They taught the provision of a garment which would allow
temperature measurements to be recorded over relatively long
periods while the subject lives normally. They provide "apparatus
for measuring surface temperatures at points in the region of the
human body, including a garment having a plurality of temperature
sensors located therein at spaced apart positions, and means for so
storing signals representing output signals from the sensors that
the relationship of each signal time of occurrence can be
retrieved".
In particular, they indicate a preference for the storage means to
be mounted on the garment. According to Claim 1 of U.S. Pat. No.
4,055,166, the garment and the means for storing signals are
integral,. In Claim 1 of GB 1,492,803 the apparatus includes a
garment and Claim 4 and various other dependent Claims describe a
brassiere which includes sampling and storage means being integral
with the brassiere.
Simpson and Green make it clear that, in relation to measurements
of temperature on the breasts, the garment may be a brassiere. They
teach a brassiere for measuring surface temperatures of the breasts
at predetermined points, including a plurality of temperature
sensors positioned in each cup of the brassiere the sampling and
storage means being integral with the brassiere.
Their underlying contention is that "The circadian rhythm of breast
temperature is regarded as normal feature of the mammary tissue
differentiation--a response possibly of a target organ to tides of
hormones in the circulation (e.g., 24-h variations in prolactin;
menstrual variations in oestrogen). Consequently alterations of the
circadian rhythm characteristics occur in breast pathology of which
cancer is one example. In this situation the rhythm is sometimes
absent and often of altered level and phase. It follows that
monitoring breast temperature rhythm over daily and perhaps monthly
intervals will be valuable in detection and characterization of
disease, e.g., cancer." From this and other statements in the
specification it is clear that these authors did not contemplate
the application of their invention in the assessment of the future
risk of developing cancer and that it was limited to detection of
and characterizations of actual lesions.
The Simpson and Green patents teach a brassiere fitted with
temperature sensors positioned at points where tumors have been
shown to occur most frequently--at one, two and three o'clock, over
the nipple and at nine o'clock on the left breast, and on the right
breast there is a similar concentration of sensors over the upper
outer quadrant, that is at nine, ten and eleven o'clock with a
sensor over the nipple and one at three o'clock. They do
contemplate different positioning of the sensors and that a
different number may be deployed.
What is quite clear, however, is that their device as described, is
a garment fitted with temperature sensors and having means for
storing signals from the sensors included with or integral with the
garment. It is also quite clear from the detailed descriptions and
claims that when the apparatus is to be used on the human breast,
the garment is to be a brassiere. They also clearly describe, in
Claim 6 of each patent, the use of a heat shield to prevent outward
heat flow through the sensor.
Simpson has since suggested that the device, which is the subject
of the test described in the two patents, is subject to `noise` and
that this is due to other vasomotor phenomena. He has suggested
that "The problem with the method is not the signal, but the noise
from these sources." Sir James Young Simpson Memorial Lecture, J.
R. Coll. Surg. Edinb., 41, June 1996. He goes on to suggest that
future developments could include Doppler ultrasonography applied
to the internal mammary artery and volumetric analysis of the
breast and its component tissue using magnetic resonance
imaging.
In the source quoted above, Simpson makes it clear that his
developments are nowadays directed at trying to predict, from
temperature measurements, which breasts may develop cancer
later.
Although Simpson and Green appear to have been the first workers to
make a serious attempts at detecting breast cancer by observing
breast surface temperatures, theirs is not the only work. Detectors
for actual cancer lesions based on breast surface temperature are
still being developed and this is somewhat surprising since most
authorities believe that tumors large enough to find by this method
are already likely to be have progressed so far as to carry with
them fatal consequences.
One example is BreastAssure.TM. made in the U.S.A. by HumaScan Inc
of Cranford, N.J. The makers claim that this device is the subject
of two U.S. patents which expired on May 22, 1998 and a Canadian
patent expiring on Aug. 24, 1999; these are all believed to be to
Z. L. Sagi. Financial literature on the company states the product
"consists of a pair of mirror-image, non-invasive, lightweight,
disposable soft pads, each of which has three wafer-thin segments
containing columns of heat sensitive chemical sensor dots that
change color from blue to pink reflecting an 8.5.degree.
temperature range from 90.degree. to 98.5.degree. F. When placed
over a woman's breasts, inside her brassiere for a period of 15
minutes, the device registers skin temperature variations due to
heat conducted from within the breast tissue to the surface of the
skin. By comparing the mirror-image temperature differences between
the two breasts registered by the device, the physician can
objectively quantify if there is abnormal unilateral breast thermal
activity, which is considered significant if there is a 2.degree.
F. or more temperature difference between each breast in the same
mirror-image location. Based on clinical studies at major medical
centers, the threshold tumor size that resulted in significant skin
temperature differences detectable with the device was as small as
5 mm in size." It may be worth noting that, according to some
authorities, cancers of this size may well have already
metastasized. Other experts to whom I have spoken doubt whether 15
minutes is an adequate time for any device placed on or over the
breasts to equilibrate with breast temperature on a consistently
reliable basis.
The manufacturer claims that according to industry sources, the
majority of breast tumors are, on average, at least 15 mm or larger
before they are palpable by most experienced clinicians. Literature
which I have seen suggests that 15-20 mm is the range in which most
become tumors become palpable.
Another recent entrant to this field is Biofield Inc of Roswell,
Ga., U.S.A., with its ALEXA.TM.1000 system. According to material
released by the company onto the Internet, this employs single-use
sensors and a measurement device to analyze changes in cellular
electrical charge distributions associated with the development of
epithelial cancers such as breast cancer. Sensors are arranged on
the skin surface in and around the quadrant of the breast where a
suspicious lesion has been identified and in corresponding
locations on the asymptomatic breast. Sensor readings are measured
and analyzed using a pre-programmed algorithm. The technology is
claimed to be based on the observation that epithelial cancers are
characterized by uncontrolled recurrent cell proliferation of rapid
cell division. As these cells divide, an electrical charge is
released. This results in a disruption, or depolarization, of the
charge distribution found in normal epithelial tissue. Moreover,
the depolarization appears to be progressive as cell transformation
and carcinogenesis occur. It is claimed that this depolarization is
measurable at the skin surface in the form of electrophysiological
differentials. The final output is a single numerical and objective
value, from 1 to 30. The result of this test is claimed to provide
an indication of the proliferation level, which is related to the
probability as to whether a lesion is malignant or benign. The
manufacturer claims that a task force sponsored by the European
School of Oncology has reported on the measurement of
electropotentials from the breast as a possible method of detecting
breast cancer. This report summarizes the background and early
results and suggest that this technique may have a role in the
diagnosis of both palpable and non-palpable breast lesions. U.S.
Pat. Nos. 5,427,098; 5,560,357; 5,415,164; 5,217,014; 5,320,101 and
5,099,844 all appear to relate to this technology. I have been
unable to verify these claims from enquiries made with the European
Institute of Oncology, which is a current trial center for the
instant invention.
Lifeline BioTechnologies Inc, another U.S. company, has two
products which are claimed to increase the chance of finding
potential breast cancers at an early stage. The KELLY MONITOR is a
detection aid for early breast cancer apparently intended for use
as a non-invasive complement to mammography. It consists of sensors
and a small portable data storage unit, worn for up to forty-eight
hours in order to capture temperature patterns which are stored for
later analysis. The device dynamically monitors the physiologic
activity of the breast by means of circadian rhythm analysis. This
monitor uses a sixteen sensor array: seven for each breast, one for
the sternum, and one to measure ambient temperature and, like the
Simpson and Green disclosure, calls for placement determined by
occurrence data for breast cancer. This product uses a proprietary
template for identical placement on each breast. The manufacturer's
literature claims to use sensors which are considered
"interchangeable", eliminating the need for insulation, adjustable
resistors, and continued calibration. This commercial claim appears
to be directed in a negative manner at the Chronobra.TM., a device
based on Simpson and Green's patents which does require the use of
calibration and trimming resistors. It is not clear whether this
product is the subject of either an issued patent or a patent
application.
Unlike the other devices and products hereinbefore described, the
FIRST WARNING.TM. product is claimed to identify women who will
eventually develop breast cancer and to be a `Risk-Marker`. The
literature indicates that during the test, a custom-designed breast
temperature sensor is integrated into a cup insert for use with the
patient's brassiere, and she will be directed to place the sensors
directly within her brassiere and thus on her breast. The patient
would be required to wear the device for ninety minutes each night.
The sensor is intended to measure surface temperature over the
breast area for each breast throughout this period. The inserts are
apparently presented in several sizes to fit the wide variation in
breast sizes in the female population. According to the literature,
each sensor will detect the unique temperature patterns of the
breast. The sensors are described as connected to a miniature
storage device which is worn concealed under the clothing. The
literature indicates that at the conclusion of the test, the device
is plugged into a data storage unit which is small enough to be
placed on a bedside table. The data is transferred to the base and
the portable unit is recharged. An additional requirement described
is for a sample of saliva to be taken on a daily basis. The saliva
is placed in a small vial and stored in a refrigerator in a special
calendar/date related container until the test concludes. The
entire test lasts for thirty days. The results are then analyzed
using proprietary techniques to assess the risk factor for the
patient. The company claims that traditional statistical techniques
are not accurate enough in their discrimination of the data. The
ultimate result is an indication of high or low risk. The product
is believed to the subject of a U.S. patent application.
The practicality of this test seems to be questionable at least. It
has to be done over thirty days and thus requires an enormous level
of compliance in today's fast-moving world where many women do not
have well ordered lives which allow them to be constantly at home.
This test also has to be done for ninety minutes each night,
followed by a procedure to re-charge the monitor; it is surely
rather likely that the patient would fall asleep. The most limiting
factor, however, is likely to be the sheer cost of 30 hormonal
assays for each patient. On top of this is the question of
available laboratory capacity to carry out the tests--on the basis
of the manufacturer's own figures, they hope to generate a level of
business per `developing family practice` which would produce a
laboratory load of 3,100 hormone assays.
With the exception of the last product described, all prior art
items which I have been able to find may be called breast cancer
detection aids. As such, their use is limited, since any patient
who already has cancer has a reduced risk of survival and a
certainty of morbidity. On the other hand, any patient who tests
negative, is only negative on the day of the test and has no idea
of her future risk status.
Since most authorities now accept that about 1 in 12 women in
Europe and maybe as many as 1 in 10 in the U.S.A., dies from breast
cancer and up to 1 in 8 may develop the disease at some point in
their lives, it would clearly be of enormous benefit to be able to
identify which women are at risk and which not. By such a means of
risk-assessment, very great relief from stress could be imparted to
the majority of women. Even women found to be at risk would be much
better off since the health care system, whether public or private
insurance based, would be able to release funds to enhance their
surveillance, implement better avoidance strategies (perhaps
involving diet and nutritional supplementation) and treat them
better, should the disease eventually supervene. I estimate that in
the UK alone, having an effective means for positively identifying
those who are at risk and three quarters of those who are not at
risk, would save .English Pound.1.8 billion per annum, as well as
avoiding a vast amount of human misery.
Clearly, there is room for substantial improvement in the
management of breast cancer since the long term survival prospects,
following diagnosis, are still not very encouraging, barely
exceeding 50%. Mass campaigns directed at self-examination are not
very successful since, even when regularly practised, women who
find lumps which turn out to be malignant upon biopsy generally
detect these at a size which is lethal. This is particularly so in
young women with dense breast tissue.
It may be that today's limited success in treating this disease is
partly due to the failure to recognise pre-cancerous states in
mammary tissue as a whole. The investigation, observation and
tracking of these states would allow earlier diagnosis and would
also permit potential intervention strategies to be exploited
perhaps with marked effects on ultimate survival rates.
Work published by Simpson and others, well after the date of his
patents, includes comparative microscopy data in cancer-associated
breasts and age-matched normal breasts showing a gross excess of
focal hyperplasias in pre-menopausal cancer-associated breast
tissue. Additionally, epidemiological data are consistent with this
finding in that such tissue is subject to a 6-fold increased risk
of further primary carcinogenesis. In addition, it is now known
that premenopausal mammary tissue goes into a monthly pregnancy
rehearsal with glandular proliferation and increased blood supply.
These phenomena have been shown to produce a luteal heat cycle
which produces a variation in breast surface temperature of about
1.degree. C. in normal women (probably not at risk of cancer).
Women with cancer-associated breasts exhibit only up to about half
this amplitude. The pattern of temperature rise is also different
insofar as the temperature rise curve in cancer-associated breasts
is relatively steady and peaks earlier in the menstrual cycle than
in normals. Normals exhibit a high correlation with and dependence
upon endogenous progesterone levels during the luteal phase.
The differences in breast temperatures between `normal` women and
clinically normal women with cancer-associated breasts, measured
during the luteal heat cycle, are maximal during the few days just
after ovulation. Breast temperature variations may be associated,
at least in part, with abnormal breast arterial blood flows at
particular phases of the menstrual cycle. Significantly increased
blood flow commences at the start of the luteal phase, some
fourteen days prior to menses. The blood supply of the breast is
from the axillary artery via the lateral thoracic and
acromio-thoracic branches and also from the internal mammary
(thoracic) artery via its perforating branches. In the female, the
branches of the second, third and fourth intercostal spaces give
branches to the breast which vary in size under hormonal
bombardment. Thus although the contribution to overall elevation in
breast temperature may be greater by some arteries than others, all
exhibit a menstrual cycle of breast blood flow and all contribute
to the breast luteal heat cycle.
In any system or device for breast surface temperature measurement
which is to have broad applicability for mass screening of
populations, great attention has to be given to practicability. Any
such entity which consumes large amounts of time in setting up will
be unacceptable.
For this reason, the physical attachment of sensors to the breast
surface of subjects has not proven popular. The need to apply each
sensor separately, usually with adhesive tape, is not only time
consuming but has obvious disadvantages for the subject at the time
of removal. There is also the problem of ensuring that individual
sensors do not become detached as a result of traction on cable
connecting means employed to deliver the signal to whatever means
is employed for temperature data collection.
The use of a sensor array, integral with a brassiere, this garment
also having means for carrying a data logging device, is
apparently, the preferred implementation of the Simpson and Green
utilities. This device has the name Chronobra.TM. and Simpson has
published on this in the lay press as recently as September 1997.
It is clear from other publications on this device that, although
it has some functionality, there are inherent problems of poor
signal, intermittent signal and sometimes a complete absence of
signal, logged from certain individual sensors suggesting poor and
inconsistent contact between these and the breast surface.
Analysis of the device, an example of which I have obtained,
suggests that the problems are unlikely to be truly electrical but
are related to the structure and mechanics of the device. The
manner in which thermal sensors and the garment are integrated
involves the use of a sewn-in lining pad made of stiff material and
provided with a plurality of perforations. A plurality of thermal
sensors is each encapsulated within in a thick moulding of silicone
material which is in the shape of a cylindrical plug which is `T`
shaped in cross-section, each sensor being located in the `leg` of
a `T`. The sensor mouldings are disposed between the perforated
lining pads and the cups of the brassiere. Each perforation in the
lining pad accommodates the leg portion of one thermal sensor
moulding so as to present it to the breast surface.
I have measured the thickness of the silicone mould material
disposed about a number of sensors and in no case was this less
than 2.0 mm. However, the least thickness measured at the end of a
moulding over that surface of the sensor directed towards the
breast was 3.1 mm and in some cases over 4.0 mm. Since silicone
rubbers are highly effective insulating materials with poor thermal
conductivity it is certain that this arrangement will lead to
reduced effectiveness and possibly to repeated low readings.
Simpson and Green's disclosures call for insulating means to
prevent heat loss and this may be why they employed a large plug of
the selected material behind the sensors. However, to employ such a
material over the face of the active thermal sensing element
suggests a fundamental misunderstanding of the principal aim at
hand. This is the measurement of small variations in temperature of
a target in an ambient environment, the temperature of which is not
vastly different from the target itself. Under these circumstances,
the principal aim is only likely to be met either when there is no
barrier at all or, if there is one, it has high thermal
conductivity and minimal thickness.
Further analysis of the subject Chronobra.TM. device, both on and
off subjects, suggests other reasons why instances of intermittent
or absent signal are encountered. First, the integral construction
of the sensor array and brassiere called for by the Simpson and
Green patents and embodied in the use of a lining pad, leads to a
rather rigid cup construction which resembles a rounded modified
cone. In most women, the breast surface is profoundly convex on the
lower aspect and somewhat concave on the superior aspect. Such a
mis-match of profiles explains why, in a number of cases, the
sensor mouldings of the upper aspect of the cups do not come into
contact with the superior breast surface at all. Such a brassiere
must, of course, be available in all rational sizes if a general
population is to be tested. This inevitably increases the cost and
level of inconvenience associated with the test. Mounting the data
logging device on the brassiere--which reads for the Simpson and
Green patents--between and below the cups, introduces traction on
the brassiere and exacerbates the non-contact problem by pulling
the upper surfaces of the cups away from the breast surfaces. Each
fine, twisted pair of sensor connecting leads extends from the
sensor to the data logging device separately and without further
protection. This not only makes for an untidy appearance but also
increases the risk of tangling and traction on individual sensors.
Finally, this device does not use any form of true calibration and
therefore it cannot be argued that the output from the sensors
represents accurately any particular absolute temperature.
OUTLINE OF THE PRESENT INVENTION
This invention is based on the observation that, in general,
pre-cancerous states of the breast as well as cancer may be
recognised by observing beast temperature.
As noted, prior art devices are in the form of sensors physically
attached to the breast surface, brassieres with integral sensors or
brassiere inserts which fit within and which are retained by the
cups of a brassiere. Furthermore, with only one exception, all of
those which I have been able to find are concerned with the
detection of an actual cancerous lesion.
In marked contradistinction to prior art devices, the instant
invention is neither physically attached to the breast surface and
is also neither a brassiere nor a brassiere insert. Furthermore, it
is directed, by means of the function of its structural elements,
towards the assessment and determination of the risk of developing
cancer later in life, by the measurement of breast temperatures,
over a period normally of one hour. Notwithstanding this, the
instant invention may be used to detect breast cancer.
In the system of the instant invention, a universal harness, only
one size of which is needed to fit all subjects, comprises two
flexible, flat, ring-like contactor pads, united anteriorly by a
short, adjustable, elasticated strap and united posteriorly by a
longer, adjustable and openable strap. The harness may be used in
conjunction with the patient's own brassiere or without a
brassiere, according mainly to the choice of the investigator. Each
contactor pad comprises substantially similarly sized and shaped
inner and outer layers of flexible, compressible and extensible
material which, conveniently, may be neoprene, provided with
suitable flexible facing fabrics, such as the nylon material known
commercially as Lycra.TM..
Each contactor pad layer has two extension tabs, disposed about
opposite ends of a diameter, for the attachment of the short
anterior strap and the longer, openable, posterior strap. The
contactor pad layers each have a central hole which is so sized
that it will accommodate the areolar area of the majority of women
and is conveniently about 50 mm in diameter. The outer diameter is
conveniently about 100 mm. The inner and outer contactor pad layers
are laid one over the other such that the extension tabs are
aligned and are then stitched together around the circumference of
the central hole.
An array of thermal sensors, preferably but not necessarily four in
number, is disposed about the inner surface of the inner contact
pad layer in a regular manner along the circular center line lying
between the inner and outer boundaries. The sensors are preferably
of the analogue type which produce a current in proportion to
temperature and are housed in a transistor can package. Each sensor
of this type has three wire legs which are introduced through the
material of the inner contactor pad layer. The neoprene material
effectively self-seals against each sensor leg. The sensor cans are
completely unsheathed, having no additional covering of any kind in
order to ensure contact with the breast surface and to maximise
thermal transfer.
The three legs of each can package each engages a small disc-like
moulding, provided with through holes disposed, in its periphery,
120.degree. apart. The legs are then be bent over at the periphery
of the disc providing initial securing means for this assembly.
Cable connecting means are in the form of light, flexible plastics
sheathed outers each provided with a plurality of twisted pairs of
inner cables, the number of pairs being the same as the number of
sensors provided on each contactor pad. It is strongly preferred
that a different color outer cable covering is used for each
contactor ring and that a convention is adopted, during use, that
the first color is always used with a first breast and that the
second color is always used with a second breast. Wiring is
accomplished according to a novel strategy directed to towards
ensuring that individual sensors are never subjected to traction in
normal robust use.
Flexible insulating and cushioning means are introduced intimately
about the sensor legs and connections and between the contactor pad
layers which are then sewn together to complete the contactor pads.
These are soft and compressible and have a `bulked` feel. The
contactor pads are `handed` and the sheathed outer of the cables
are directed medially. A short, elastic, adjustable anterior strap
is sewn between medial tabs on each contactor pad. A longer
elasticated, adjustable and openable posterior strap, is sewn to
laterally directed tabs on each contactor pad.
The colored connecting cables terminate within the case of a
monitor unit and preferably have a softness such that they drape
readily under their own weight. This monitor is provided with
electronic micro-circuitry which provides timing and memory means
capable of polling each sensor, every sixty seconds, for one hour
and storing the data so collected. The sensors are preferably
independently calibrated to within 0.01.degree. C. using pre-set
potentiometer means located within the monitor unit. The monitor is
preferably powered by a re-chargeable nickel hydride battery. The
monitor is provided with a series of colored LEDs which indicate
status of the system under a variety of conditions.
The temperature sensing cycle is initiated by depressing a plunger
and the monitor unit switches off automatically at the end of the
sensing cycle.
Data stored within the monitor is downloaded to a host PC via an
interface unit to which it is attached with suitable connecting
cable and plug means. The interface also provides charging means
and this function is activated upon connection, whether the monitor
is downloading or not. Conveniently, the interface will provide
charging services for a plurality of monitor units, typically
twelve at one time. The host PC, which preferably has a 100 MHz
processor or better and uses the Windows 95.TM. operating system,
is provided with a dedicated programme written, for instance, in
Turbo-Pascal.TM. for Windows.TM.. This programme is capable, under
keyboard or mouse command, of communicating with the monitor unit,
initiating data download, capturing and saving downloaded data and
displaying this in graphical and tabular form for each sensor. In
addition the programme provides means for pictorial graphic display
of the temperature measured by each sensor, at each polling,
displayed in its correct spatial position on each breast.
Re-setting the monitor unit for further use is normally carried out
from within the host computer, using software means, however,
should there be a reason to abort a sensing cycle and start
another, this is accomplished by depressing a re-start button
mounted sub-flush with respect to the surface of the monitor
case.
In use, the subject to be investigated, who will generally be
between 20 and 50 years of age and in any event will not have
reached the menopause, is counselled upon recruitment as to the
nature of the test. Some time prior to the test, she is provided
with a urine dip test kit which will indicate the day upon which
she has a marked rise in luteinising hormone. She is also provided
with a series of sterile bottles in which to collect a series of at
least three early morning saliva samples which, when the series is
complete are forwarded, in the container provided, to a suitable
laboratory equipped to carry out assays of progesterone levels.
These results are used to measure and predict the most suitable
date in the subject's next cycle to carry out the breast
temperature test.
On the appropriate day, the subject is called to the location where
the test is to be conducted. In a warm environment, where the
ambient temperature should be 24.degree. C..+-.2.degree. C., the
subject is fitted with the harness of the instant invention. The
patient may, in addition, wear her own brassiere if she wishes, or
a sports type elasticated brassiere or no brassiere. She should,
however, wear a substantial and close fitting over garment, to
limit or prevent any generalised heat loss. It is essential that
identification details relating to both the subject and the monitor
unit are recorded together and that the integrity of this combined
information is maintained. Only one size of the instant harness is
normally provided and required.
The sheathed connecting leads between the harness and the monitor
unit are led out from under the lower margin of the over garment.
To start the test, the assistant, helper or other designated person
depresses the plunger on the monitor unit, observing that the
`start` LED illuminates, to confirm initiation of the test. It will
be found convenient if the subject is provided with a dressing gown
in order that the monitor unit may be placed in a pocket during the
test. Throughout the test period, the subject should be encouraged
to sit quietly and avoid exertion and should not imbibe hot or
stimulating liquids. At the end of one hour the test will be
complete and the patient may return to a private cubicle to doff
the harness and dress in her normal clothing prior to departure
from the test center.
The data from the monitor unit used with the subject is downloaded
into the computer, as hereinbefore described and evaluated by a
skilled trained person capable of comparing the subject's breast
temperature data with known norms with a view to reaching a
conclusion concerning whether or not subject may be at risk of
developing breast cancer at a future date.
In the event that this conclusion is positive, the subject would be
informed promptly and invited back to participate first in a
re-test and then in other tests. The purpose of these is to
establish whether or not she may have existing cancer since,
although the object of the test of the instant invention is not,
primarily, to detect actual cancers, there will be some subjects
who come forward who do have the undiagnosed condition. If she is
negative to other tests for cancer, she will be informed that she
is at a significant risk of developing breast cancer subsequently.
This knowledge, allows surveillance, prevention and future
intervention strategies to be planned and implemented. These
factors, in turn, improve the chances of preventing the disease or
should it prevail, successfully treating it at an early stage.
On the other hand, if the test is negative, the subject will also
be so informed. In this event, the subject may well be reassured,
however, she should be advised that she should return for
re-testing at a suitable interval which may be, say, two years. In
any case, a follow up record and call-forward system should be
maintained in order that any subjects which test negative can be
called for a re-test after a suitable period.
The foregoing equipment of the instant invention is undergoing
human trials at The European Institute of Oncology, Milan, Italy
according to a protocol which reflects the general method of use
immediately hereinbefore described. Progesterone assay services are
being provided by BioClinical Services Limited, Willowbrook
Laboratories, St Mellons, Cardiff, Wales, UK.
Accordingly it is a first object of the present invention to
provide a device capable of making accurate measurements of
temperatures on the surface of the human breast, particularly the
female breast.
It is a second important object of the present invention to
reliably record and store measurements of temperatures on the
surface of the human breast.
It is a third important object of the present invention to
manipulate and display temperature data collected from the surface
of the human breast.
It is a fourth important object of the present invention to provide
a method for the assessment of the risk of subsequent development
of breast cancer in women who do not currently have the
disease.
It is yet another object of the present invention to provide a
method for the detection of breast cancer in women.
Other features, objects and advantages will become apparent from
the specification and drawings in which:
DESCRIPTION OF THE DRAWINGS
FIG. 1, is a diagrammatic perspective view indicating the principal
elements of the system of the instant invention.
FIG. 2, is a diagrammatic, perspective, view of a most preferred
embodiment of a harness and monitor unit according the present
invention, showing the inner, functional surface of the
harness.
FIG. 3, is a diagrammatic, perspective, view of the outer surface
of the harness of FIG. 2, with connecting cables foreshortened for
clarity.
FIG. 4, is a plan view of four contactor pad layers, employed in
the construction of two contactor pad assemblies, which are
deployed in the harness of the present invention.
FIG. 5, is a plan view of the surface of one contactor pad
assembly, according the present invention, showing a thermal sensor
array.
FIG. 6, is a cut-away plan view of one contactor pad assembly, from
the outside or non-contact surface, showing sensor securing means
and wiring arrangements.
FIG. 6a, is an enlarged portion of FIG. 6, showing more clearly the
wiring arrangements for sensor means.
FIG. 7, is a partial, perspective, pseudo-section view of a segment
of a contactor pad assembly, along line A.sub.1 -A and A.sub.1 -B
showing construction details, a sensor and capture means
therefor.
FIG. 8, is a diagrammatic view of a screen print, produced on a
visual display unit (VDU) by a dedicated computer program, showing
a pictorial and graphical representation of breast surface
temperature data produced according to the present invention.
FIG. 9, is a block diagram of the circuitry employed in the instant
system.
FIG. 10, is a diagrammatic representation of the LED display used
on the monitor unit of the instant system.
DETAILED DESCRIPTION OF THE INVENTION AND METHOD OF USE
With general reference to FIGS. 1-10, there is provided a system
10, which allows breast surface temperatures to be measured, with
great reliability, for periods of an hour or more at any desired
rational sampling rate. Collected breast surface temperature data
may then be downloaded into a computer, which forms part of the
system, for elaboration using proprietary software which is also
part of the system.
Preferred Embodiment
In the preferred embodiment, system 10, comprises the principal
elements of a mechanical adjustable harness 12, having a
permanently connected remote monitor unit 14, an interface unit 16
and a host personal computer (PC) 18. Host PC 18, comprises a
normal processor, VDU, mouse and keyboard (not illustrated).
It is important to note that mechanical adjustable harness 12, is
not physically attached to the breast with adhesives or tape.
Neither is harness 12, a brassiere, since it cannot provide support
for the breasts and does not contain them, nor is it a brassiere
insert since it is not necessary to use it in conjunction with a
brassiere. Finally, harness 12, is not a garment, since it has no
purpose or use as apparel and is used only in relation to its
specific function, immediately hereinafter described.
System 10, is directed, by means of the function of its structural
elements, towards the assessment and determination of the risk of
developing cancer later in life, by the measurement of breast
temperatures, over a period normally of one hour. Notwithstanding
this, the instant invention may be used to detect breast
cancer.
Harness 12, only one size of which is needed to fit all subjects,
comprises two flexible, flat, ring-like contactor pads 20 and 22,
united anteriorly by a short, adjustable, elasticated strap 24 and
united posteriorly by a longer, adjustable and openable strap 26.
Harness 12, may be used without a brassiere or in conjunction with
the subject's own brassiere, if she indicates that she is
discomforted without a supporting undergarment, according to the
decision of the investigator. Each contactor pad 20, 22 comprises
substantially similarly sized and shaped inner and outer layers 28;
30 and 32; 34, of flexible, compressible and extensible material
preferably neoprene sheet 2.5 mm to 3.00 mm in thickness and
provided with suitable flexible facing fabrics, such as the nylon
material known commercially as Lycra.TM..
Each of contact pad layers 28-34, has two extension tabs 36-50,
disposed about opposite ends of a diameter, for the attachment of
anterior strap 24, and posterior strap 26. Contact pad layers 28;
30 and 32; 34, which are cut-out blanks, each have a central hole
52-58, preferably of 40 mm of diameter prior to assembly. During
assembly, hereinafter described, this diameter increases to about
45 mm which is adequate to accommodate the areolar area of the
majority of women. The outer diameter is preferably 100 mm before
assembly and this decreases minimally upon assembly.
Contact pad layers 28-34, are laid one over the other, in pairs,
for sewing, such that extension tabs 36-50, are aligned. By way of
example, with particular reference to FIGS. 6 and 7, contact pad
layers 28; 30, would be laid one over the other, aligned and then
stitched together around the circumferences of central hole 52; 54.
This is preferably accomplished with a zig-zag sewing machine set
to a relatively large stitch and relatively low tension. The
general appearance of the stitching is represented at 60. With some
care and practice it will be found by those skilled in the art but
not this novel technique, that the contactor pad layers, for
example 28 and 30, may be pulled together in such a manner that the
facings, two of which are indicated at 62 and 64, oppose at a join
lying centrally between them, such that the neoprene itself is not
exposed. This novel arrangement, together with other measures
described hereinafter, imparts a pleasing `bulked` feel to the
construction of contactor pads 20 and 22.
Eight sensors 66-80, are arranged as two arrays 82 and 84, each of
four sensors 66-72 and 74-80, respectively, on each of the inner
contacting surfaces 86 and 88, of contactor pads 20 and 22,
respectively. Sensor arrays 82 and 84, are disposed about inner
contacting surfaces 86 and 88, in a regular manner, 90.degree.
apart along the circular center lines 90 and 92, lying between
inner and outer boundaries 94; 96 and 98; 100, of 20 and 22,
respectively. If, for reasons of explanation only, the upper
portion of the vertical mid-line of each breast is regarded as
North, the sensor positions are at North-East, South-East,
South-West and North-West. By virtue of this arrangement, sensing
means are provided to each of the well recognised anatomical
quadrants of the breasts.
Sensors 66-80, are of the type AD592 supplied in a transistor can
package of the generic type TO-92 and described in more detail,
hereinafter.
The method of deployment of sensors 66-80 and novel features of the
associated wiring will be described with particular reference to
FIGS. 5, 6 and 7, especially in respect of sensor 72. Each of
sensors 66-80, has three stiff fine wire legs each about 1 mm wide,
0.5 mm thick and 10 mm long, closely disposed, 120.degree. apart,
those of sensor 72, being indicated at 102, 104 and 106. Each of
legs 102, 104 and 106, is pushed carefully and firmly right through
the material of inner contact pad layer 28. Advantage is taken of
the small closed cell structure of the neoprene material which
effectively renders the punctures of the material self-sealed by
close compressive contact against each of legs 102, 104 and 106.
All faces of type TO-92 sensor can package 108, are active and this
is completely unsheathed, having no covering of any kind. This is
in order to maximise contact with the breast surface and thermal
transfer.
When correctly assembled to inner contact pad layer 28, legs 102,
104 and 106, of can package 108, protrude through the neoprene, and
engage a small disc-like moulding 110, adapted by the provision of
through holes 112, 114 and 116, disposed 120.degree. apart near its
periphery 118, to receive each of them, respectively. Disc moulding
110, is slightly larger than can package 108 and this causes legs
102, 104 and 106, advantageously to splay somewhat (not shown). By
gently compressing disc moulding 110 and can package 108, together,
against the neoprene of inner contact pad layer 28, the available
length of legs 102, 104 and 106, protruding through holes 112, 114
and 116, in disc moulding 110, may be extended. Legs 102, 104 and
106, may then be bent over at periphery 118, of disc moulding 110,
providing initial securing means for this assembly. As previously
indicated, this method of introduction and assembly is applied to
all of sensors 66-80 of both contactor pads 20, 22.
Cable connecting means between sensors 66-80, and monitor unit 14,
are in the form of light, flexible plastics sheathed outer cables
120 and 122, each provided with four twisted pairs of inner cables
124-130 and 132-138, the number of pairs being the same as the
number of sensors provided on each contactor pad. For reasons of
clarity it has been necessary to exaggerate the size of inner
cables 124-130 and 132-138, in FIGS. 6 and 7.
A different color outer is used for each of sheathed outer cables
120 and 122. This is to serve an important convention, during use,
according to which the same first color is always used for the
sheathing outer of the cable serving the left breast and similarly
the same second color is always used for the sheathing outer of the
cable serving the right breast. In the preferred embodiment I have
used grey for the sheathing outer of the cable serving the left
breast and violet for the sheathing outer of the cable serving the
right breast, however, the important point is that the color
difference must be obvious.
Sheathed outer cable 120, is secured, ultimately, in the angle 140,
formed between extension tab 142 and the main body portion 144, of
contactor pad 20, emerging along a generally medial path between
layers 28 and 30. Similarly, sheathed outer cable 122 is secured,
ultimately, in the angle 146, formed between extension tab 148 and
the main body portion 150, of contactor pad 22, also emerging along
a generally medial path between layers 32 and 34.
Extension tabs 142 and 148, provide anchor points for first and
second ends 152 and 154, respectively, of adjustable, elasticated
strap 24. First and second ends 152 and 154 of adjustable,
elasticated strap 24, are secured in place by sewing.
Wiring details will be described with particular reference to FIGS.
6 and 7 and especially contactor pad 20. However, it is to be noted
that wiring routing is accomplished according to a novel strategy
directed towards ensuring that individual sensors are never
subjected to traction in normal robust use. In particular,
connections to those sensors which lie medially namely 66 and 68,
in the case of contactor pad 20, are closest to the point of
entry/emergence 156, of sheathed outer cable 120, in angle 140.
Connections to sensors 66 and 68 are provided by twisted pairs 124
and 126, of sheathed outer cable 120, from which a sufficient
length of sheathing is stripped away to allow them to be extended,
in opposite directions, right around inner surface of inner sewn
seam 160, disposed between contact pad layers 28; 30 and about
central hole 52/54, before being routed back to sensors 66 and 68.
At the point furthest away from point of entry/emergence 156,
twisted pairs 124;126, are twice passed under and over one another,
indicated at 158 and then drawn gently against the inner surface of
seam 160, in such a manner that the tension applied does not cause
distortion of central hole 52/54.
The restraint provided by routing twisted pairs 124 and 126, `out
and back` and by doubly overlapping them, before re-directing them
to sensors 66 and 68, together with other measures shortly
hereinafter described, provides such a high level of protection
against traction on the sensors that it is not necessary to apply
this strategy to remaining two twisted pairs 128 and 130, which are
connected to sensors 70 and 72, which although furthest away from
point 156, are shorter. The routing strategy may, however, be
applied to twisted pairs 128 and 130, in full or in part, if so
desired.
Sensor connection details will be described with particular
reference to sensor 72. In FIG. 6, it may be seen that, by way of
example, twisted pairs 128 and 130, each have a short section
untwisted to provide single line connecting portions, indicated at
162;164 and 166;168, for sensors 70 and 72, respectively. As may be
seen with brief reference to FIG. 7, very short bare wire ends,
indicated at 170;172, are provided on each of 166;168,
respectively. Bare wire ends, 170;172, are soldered to legs 102 and
104, respectively of sensor 72, leg 106 not being required in the
circuitry employed.
Insulating means, which are also flexible cushioning means and
adhesive means, are in the form of a hot melt insulating and
sealing compound such as that supplied by Messrs Bosch AG, Germany,
which is soft-setting and also translucent when initially cured.
With contactor pad layer 30 gathered and held clear, the compound
is introduced intimately about sensor legs 102-106 and soldered
bare wire ends 170 and 172. This process is repeated for all sensor
connections on both contactor pads 20 and 22. The process is
extended by spreading a layer, several millimeters thick, over and
about twisted pair connecting wires 124-130 and then, all over the
interior of contactor pad layer 28. Particular attention is paid to
the area about and around the inside of seam 160 about central hole
52/54. Contactor pad layer 30, is then released and the compound
applied carefully in the area indicated at 174, in FIG. 6, where
sheathed outer cable 120, upon sewing, comes to lie within the
outer margins 96 and 100, of contactor pad layers 28; 30. The
compound mass is indicated at 176, in FIG. 7. At a point when
compound 176, has begun to cure but is still generally extrudable,
contact pad layers 28; 30, are pressed together and then sewn
around outer margins 96 and 100, to form outer seam 178, in a
manner substantially similar to that hereinbefore described with
reference to seam 160, of central hole 52/54. When constructed with
the materials and assembled according to the method immediately
hereinbefore described, contactor pads 20 and 22, are soft,
flexible and formable and have a pleasing, compressible, `bulked`
feel.
Completed contactor pad assemblies 20 and 22, are `handed` left and
right by virtue of differently colored sheathed outer cables 120
and 122, each being directed medially. Contactor pad assemblies 20
and 22, are fitted with a short elasticated and adjustable anterior
strap 24, by sewing respective first and second ends 152; 154,
thereof, to medially directed tabs 142 and 148, respectively, on
contactor pads 20 and 22. Medially directed tabs 142 and 148, are
formed during the sewing together of 34; 38 and 42; 46, according
to the procedure referred to in the preceding paragraph.
A first portion 180, of a longer elasticated, adjustable and
openable posterior strap 26, is sewn to laterally directed
extension tab 182, on contactor pad 20. Free end 184, of 180, is
oversewn to prevent fraying. A second portion 186, of strap 26, is
fitted with a slot-ring adjuster buckle 188. Second portion 186, is
sewn to remaining laterally directed extension tab 190, on
contactor pad 22, to complete the construction of harness 12.
Colored sheathed outer cables 120 and 122, are preferably about 900
mm in length and are of a softness such that they drape readily
under their own weight. Cables 120 and 122, terminate within the
case 192, of monitor unit 14.
With particular reference to FIGS. 9 and 10, monitor unit 14, has
electronic micro-circuitry based around a PlC16C65 microprocessor.
This is used to control the data collection, storage and subsequent
downloading of the recorded data. Monitor unit 14, receives input
from sensors 66-80, which are precision temperature monitor ICs,
type AD592 (Analog Devices Inc., Mass., U.S.A.) having three fine
wire connecting legs, only two of which are used in the electrical
circuit. This type of IC is of the `temperature in--current out`
type and has excellent linearity and stability over the required
operating range. Although up to sixteen AD592 sensors can be
monitored and information from them recorded and stored in monitor
unit 14, only eight are used in this preferred embodiment. Each of
sensors 66-80, is polled in turn and this is achieved by
multiplexing each of them in sequence, though this occurs with
extreme rapidity. Analogue multiplexers, type AD506 (Analog Devices
Inc., Mass., U.S.A.) are used to achieve this and the polling
routine is run every sixty seconds and continued for one hour. Each
of the sensors are individually calibrated using analogue
multiplexers to switch in two calibration resistors for each
individual sensor. The calibration resistance values are set by an
independent calibration reference laboratory, prior to supply to
any end user, to establish both zero and absolute current values
against calibrated reference temperatures, to within 0.01.degree.
C. By these means, and in contradistinction to prior art devices
intended for mass screening of breast surface temperatures, it is
established that temperatures measured with the device are both
accurate and absolute. The use of absolute calibration in the
instant system is the underlying reason for the permanent
connection between harness 12 and monitor 14, via cables 120 and
122. Each of the readings from sensors 66-80, are fed into an
operational amplifier, which conditions the signal so that it may
be processed. This is achieved by converting the analogue signal
into a digital one using a 12-bit analogue-to-digital converter.
Once in digital form, the data is stored in two 32K static RAM
chips; the operation of writing and addressing being controlled by
the microprocessor.
The time between readings and their duration is controlled by the
microprocessor. After a set of readings has been taken, the
readings are stored in the static RAM until the microprocessor is
instructed to download data to host PC 18. The interaction between
host PC 18 and monitor unit 14, is achieved by using a serial RS232
interface link. Commands are sent to the microprocessor of monitor
14, which controls the outflow of data to host PC 18.
System variables, such as duration of the testing cycle and time
between readings, can be set from within host PC 18 and downloaded,
via the RS232 link to monitor unit 14, where they are stored in a
non-volatile EEPROM. Once in the EEPROM, these new values will be
applied to the taking of readings. These are protected `system
engineer` functions and cannot ordinarily be accessed by persons
using system 10, for measuring breast surface temperatures.
Power for monitor unit 14, is provided by a rechargeable PP3 9 volt
Nickel hydride battery and voltage levels are controlled using
regulator chips to set the correct voltage levels. Separate voltage
levels are used for the analogue and digital parts of the circuit
in order to reduce interference.
Monitor unit 14, is provided with a series of colored LEDs, best
seen in FIG. 10. LED 194, is green and is lit briefly when the test
cycle is started and every sixty seconds, thereafter, when sensors
66-80, are being polled for the purpose of taking readings. LED
196, is red and is lit steadily during the process of downloading
data to host PC 18 and briefly during the process of re-setting,
both hereinafter described. LED 198, is also red and is lit
steadily in the event that monitor unit 14, is faulty and flashes
regularly when a test cycle is completed. LED 200, is amber and is
illuminated briefly when a manual re-set operation is carried out.
LED 202, is green and is lit steadily when the battery of monitor
unit 14, is being charged.
A temperature sensing cycle is initiated by depressing a plunger
204 and keeping it depressed for 2 seconds. Thereafter, depressing
plunger 204, again has no effect. Although re-setting is normally
carried out from within host PC 18, should there be a reason to
abort a sensing cycle and start another, this may be accomplished
by depressing a sub-flush manual re-set button 206, mounted in case
192, of monitor unit 14.
Upon completion of a testing cycle, monitor unit 14, is attached,
via a connecting cable 208, which extends from socket 210, in case
192, to one of a series of substantially similar sockets
exemplified by 212, on interface unit 16, as may be seen with
reference to FIG. 1. Connecting cable 208, has substantially
similar plugs 214 and 216, at both ends and is thus fully
reversible. Interface unit 16, is permanently linked to host PC 18,
by cable means. Interface unit 16, provides charging means for
monitor unit 14 and this function is activated upon connection and
continues whether monitor unit 14, is downloading or not.
Interface unit 16, provides plug-in charging and download services
for a plurality of monitor units, typically up to twelve at one
time, thereby facilitating the use of system 10, in high traffic
clinic-based breast screening programmes.
Downloading of data stored within monitor unit 14, is accomplished
by first selecting the channel to which socket 212, provides
access. This is achieved by serially depressing a selector
push-switch 218, until a reference LED 220, adjacent to socket 212,
illuminates. As this is done it will be noticed that green LED 202,
on monitor unit 14, illuminates and remains lit until 14, is
disconnected from interface unit 16. Host PC 18, used for
development, has a 100 MHz Pentium.TM. processor although most PCs
having a 486, 100 MHz processor or better and capable of running
the Windows 95.TM. operating system are adequate and the fact that
most entry level machines are now much faster than this has no
deleterious effect. Host PC 18, is provided with a dedicated
programme written in Turbo-Pascal.TM. for Windows95.TM.. This
programme provides, under keyboard or mouse command, communication
with monitor unit 14, via the RS232 link. Simple commands initiate
data download, capture and saving of downloaded data, and display
of the data in graphical and tabular numerical form for each of
sensors 66-80. In addition the programme provides means for
pictorial graphic display of the temperatures, measured by each of
sensors 66-80, at each polling, displayed in their correct spatial
positions on each breast.
Preferred Method of Use in Screening for Risk of Breast Cancer and
Detection of the Disease
The primary intended use for system 10, is in screening women
between 20 and 50 years of age and who have not reached the
menopause, to detect whether or not they may be at risk of
developing breast cancer at some future date. System 10, is so
designed that it may be readily used in large populations of women,
within short time scales and involves the accurate measurement of
breast surface temperatures.
Reliable epidemiological data exist on the incidence of breast
cancer which suggest that as many as 1 in 12 women in Europe and
perhaps 1 in 10 women in the U.S.A., dies from breast cancer and it
is inevitable that in any large scale screening programme, numerous
subjects will be tested who actually have the disease. Since it is
also now known that breast surface temperature data, collected
accurately at the appropriate point in the menstrual cycle, using
progesterone assay to determine that point, are substantially
similar in both the at-risk-but-with-no-disease-currently-present
group and the active-disease group and further, that those data are
different from the not-at-significant-risk group, the instant
system 10, has potential for secondary use in confirmation of the
presence of active disease.
In use, the subject to be investigated using the instant system, is
counselled upon recruitment, as to the nature of the test. At least
one month prior to the test, she is provided with a home-use urine
dip test kit and a saliva collection kit. The urine dip test kit is
in the form of a series of paper strips impregnated with a suitable
agent which reacts to the surge of luteinising hormone in the urine
which occurs at ovulation, by a color change from green to yellow.
Such a test may be obtained commercially under the name
Unipath.TM.. The test is carried out by placing the strip into an
early morning urine sample, collected shortly after waking each
day, starting on the eighth day from the first day of bleeding of
the last menses and continuing until the color change is observed
upon testing. If the subject has a notional 28 day cycle, the color
change will normally occur on day 15.
The saliva sample kit (not shown) is in the form of a series of 3
screw cap sterilised 5 ml saliva tubes and a strong, small, divided
container suitable for transmission by post. On the day the color
change is observed with the urine test, the subject collects a
first saliva sample by dribbling a small amount into the first
bottle which she then re-seals. The subject then collects a further
two saliva samples on the morning of each of days 18 and 21. The
samples should be kept in a domestic refrigerator until the series
is complete.
If the color change in the urine dip test occurs earlier, probably
indicating a shorter cycle, the first saliva collection is still
made on the day the color change is observed, the second on the
third morning thereafter (leaving two clear, non-collection days)
and the third on the third morning after the second collection
(also leaving two clear, non-collection days). Once the third and
last saliva sample has been collected, the container containing all
three samples is sealed and sent, by post, to a suitable laboratory
equipped to carry out radio-immunoassay for progesterone levels.
These results are used to measure and predict the most suitable
date in the subject's next cycle to carry out the breast
temperature test. One such commercial laboratory is BioClinical
Services Ltd (BioClin International), Willowbrook Laboratories, St
Mellons, Cardiff, Wales, UK.
Based on the results of the saliva progesterone assays from the
laboratory, the investigator or investigating group select the
appropriate day for the subject to attend a test center and invite
her to do so. In a subject with a normal 28 day cycle this will
normally be day 17 of the next cycle; in women with differing
cycles it will normally be the `day 17 equivalent`.
In a warm environment, where the ambient temperature should be
maintained at 22.degree. C..+-.2.degree. C., the subject is
provided with privacy and requested to doff her upper garments.
With assistance from a female helper or nurse, the subject is
fitted with harness 12, of the system 10. Harness 12, is secured in
place with posterior adjustable strap 26. Anterior strap 24, is
adjusted so that, when 24, is under tension, the pitch of central
holes 50; 52 and 54; 56, in contactor pads 20 and 22, correspond
with the pitch of the subject's nipples. Harness 12, is then
adjusted on the breasts such that central holes 50; 52 and 54; 56,
of contactor pads 20 and 22, are disposed concentrically about the
nipples. The patient may, in addition, wear her own brassiere if
she wishes, or a sports type elasticated brassiere or no brassiere.
It is mandatory, however, that she wear a substantial and
reasonably close-fitting over garment, such as a high-neck,
medium-weight shirt, to limit or prevent any generalised heat loss.
It is essential that identification details for both the subject
and monitor unit 14, are recorded together and that the integrity
of this combined information is maintained. It will be appreciated
that only one size of the instant harness 12, is provided and
required. The subject should be provided with a lightweight
dressing gown having large pockets. I prefer to have these gowns
modified so that there is a slit in the dressing gown material,
parallel to and somewhat below the upper margin of the pocket and
extending for most of its width. The edges of this slit should be
oversewn with tape to prevent fraying and tearing.
Connecting cables 120 and 122, which extend between harness 12 and
monitor unit 14, are led out from under the lower margin of the
over garment and monitor unit 14 is passed through the slit in the
dressing gown. Monitor unit 14, is supported until the test cycle
is started. The subject is seated comfortably in the clinic setting
and this should provide as welcoming and stress-free an environment
as possible. It is helpful to provide her with reading
materials.
The structure, design and sizing of contactor pads 20 and 22 and
harness 12, in general, are such that not only is a good fit
obtained on both large and small breasts with large and small
areolar areas but excellent contact is also maintained between
sensors 66-80 and both the superior and inferior aspects of the
breast surfaces. Because contactor pads 20 and 22, are soft and
conformable they readily mould to breast curvature, even on the
concave upper aspect, unlike many prior art devices which, whatever
their functional basis, are somewhat rigid and have a consequent
tendency to `tent` over the upper aspect, often holding functional
surfaces away from the breast surface. It might be thought that the
presence of small hard sensor cans 66-80, protruding from contactor
pads against the breast surfaces would be uncomfortable or painful,
however, contra-intuitively, tests under confidentiality
arrangements on numerous subjects having breast sizes which varied
from very small, through moderate, to very large, have all
indicated that there is little awareness of the sensors at all and
if any, it was usually only brief and immediately followed donning
the harness. The term `awareness` is chosen carefully since no
subject reported pain or even discomfort. In all of these subjects,
readings were obtained from all sensors throughout a one hour test
cycle.
To start the test, the assistant, helper or other designated
person, depresses plunger 204, on monitor unit 14, for 2 seconds,
observing that green `start` LED 194, illuminates briefly, to
confirm initiation of the test. Once this has been done, monitor
unit 14, is placed in a pocket of the dressing gown. Since plunger
204, is inactivated once the test has commenced accidental or
deliberate interference with it has no effect. On the other hand,
if there is a valid reason for interrupting the test, particularly
if this involves removing or significantly readjusting harness 12,
monitor unit 14, may be manually re-set by depressing sub-flush
button 206, in case 192. The tip of a ball point pen is a
convenient implement for accomplishing this and it will be noticed
that amber LED 200, is lit briefly when this is done.
Throughout the test period, the subject should be encouraged to sit
quietly and avoid exertion and should not imbibe hot or stimulating
liquids. At the end of one hour the test will be complete and this
may be confirmed by the person in charge of the test observing that
red LED 198, is flashing regularly. The subject may then be taken
back to the private cubicle to doff harness 12 and dress in her
normal clothing, prior to departure from the test center.
At the end of a test cycle data from monitor unit 14, derived from
the subject is downloaded into the host PC 18, as hereinbefore
described during which process red LED 196 is lit steadily. As a
general rule, data collected during the first forty-five minutes or
so of the test should be discarded, since this period of time is
necessary for the contactor pads 20 and 22, sensors 66-80, over
garment and brassiere, if worn, to equilibrate and stabilise.
Thereafter, a relatively stable pattern of temperature response
from each of sensors 66-80, is a normal finding. These data are
then evaluated by a skilled, trained person capable of comparing
the subject's breast temperature data with known normal and
abnormal data with a view to reaching a conclusion concerning
whether or not the subject may be at risk of developing breast
cancer at some future date.
In the event that the conclusion concerning the risk of developing
breast cancer at some future date is positive, the subject would be
informed promptly and invited back to participate first in a
re-test and then in other tests. The purpose of these is to
establish whether or not she may have existing cancer since,
although the object of the test of the instant invention is not,
primarily, to detect actual cancers, there will be some subjects
who come forward who do have the undiagnosed condition. If she is
negative to other tests for cancer, she will be informed that,
according to the instant test, she may well be at a significant
risk of subsequently developing breast cancer. This knowledge, far
from being a prophecy of doom, allows surveillance, prevention and
future intervention strategies to be planned and implemented with
improved chances of preventing the disease or should it prevail
later, successfully treating it, at an early stage. Handled well at
counselling, it is eminently possible to engender a strongly
positive psychological response in the subject. Alternatively, if
the subject has already had other tests which suggest that she may
have breast cancer or has physical signs which suggest breast
cancer, the results from tests using the instant system may be used
to confirm or deny previous findings.
On the other hand, if the test is negative, the subject will also
be so informed. In this event, the subject may well be reassured,
even to the point of euphoria and it is incumbent upon those who
carry out the test to abjure such subjects that it is very much in
their own interests to return for re-testing at a suitable
interval, which may be, say, two years. In any case, a follow-up
record and recall system must be maintained in order that all
subjects tested can be called for a re-test after a suitable
period, no matter how short or long this may be.
Experimental Observations
In a few subjects which I have encountered, the areolar areas have
been exceptionally large and although this phenomenon has not been
seen in very small breasts, it has been seen in some of relatively
moderate size. Therefore, I have made and tested examples of
harness 12, wherein the nominal external diameter of contactor pads
20 and 22, has been made 150 mm and the diameter of central holes
52;54 and 56; 58 has been made 80 mm. This variant is, in other
respects, substantially similar to the preferred embodiment and has
therefore not been further separately described.
The foregoing equipment of the instant invention is undergoing
multiple phases of human trials at The European Institute of
Oncology, Milan, Italy according to a protocol which reflects the
general method of use immediately hereinbefore described, together
with a rigorous statistical regime applied to the evaluation of the
significance or otherwise, of data collected with this equipment
and method. In addition, experiments have been conducted where the
data collection method has been extended for several hours, in a
statistically valid subset of subjects, to investigate whether
intra-day temperature variations exist which would make a
particular time of day most suitable for testing. Multiple
experiments, conducted in accordance with the one hour testing
regime and method hereinbefore described and with apparatus
according to the present invention, have shown beyond doubt and in
marked contradistinction to the Simpson and Green Chronobra.TM.
device, that the instant invention does, indeed, collect breast
surface temperature data in human females, from all sensors, to an
accuracy of 0.01.degree. C. In trials, it has been found that the
system reaches equilibrium with the subject after about 45 minutes
and temperatures then vary only over an extremely narrow range over
the rest of testing period. Further multiple experiments, conducted
off the human breast, have shown that the system monitors ambient
temperature in the testing environment to the same degree of
accuracy. Yet further experiments have detected abnormal breast
surface temperatures in human females prior to but on the same day
that they were diagnosed by other, standard, methods, such as
biopsy and histology, as positive for breast cancer. Evaluation of
these results is continuing.
From the foregoing, it will now be apparent that the present
invention provides a system capable of making accurate measurements
of temperatures on the surface of the human breast that is clearly
differentiated from the prior art by its structure and which
incorporates means to reliably record and store measurements of
these temperatures and to manipulate and display them. Further,
that use of the instant system, according to the method
hereinbefore disclosed, constitutes a method for the assessment of
the risk of future development of breast cancer in women who do not
currently have the disease and for the detection of breast cancer
in women who may have the disease.
It will be apparent to those skilled in the art that numerous
modifications or changes may be made without departing from the
spirit or the scope of either the present invention or its method
of use. Thus the invention is only limited by the following
claims.
* * * * *